Experience

MediView XR, Inc.

• United States
• Software Development
• 1 - 100 Employee

• Quality & Regulatory Specialist

  • Aug 2022 - Present



Canidae

• United States
• Manufacturing
• 1 - 100 Employee

• Documentation Specialist

  • Mar 2020 - Jul 2022

  Documented and outlined processes and procedures across the organization, serving as a quality assurance and regulatory subject matter expert, as well as a general documentation and writing specialist. Acted as a liaison responsible for ensuring that quality, regulatory, and safety standards were maintained across all areas of the business. Collaborated across the organization to communicate priorities and quickly resolve issues related to consumer satisfaction, marketing, and quality assurance. Authored, revised, and maintained Standard Operating Procedures (SOPs) and other Quality Management System documentation in advance of notified body audit and certification. Show less



Medtronic

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Associate Supplier Quality Engineer

  • Aug 2016 - Mar 2020

  Served as liaison to suppliers of materials and components used to assemble regulated medical devices and healthcare equipment. Negotiated with external suppliers and finalized 40-50-page legal agreements to ensure consistency of quality agreements through the global supply chain to support 35 manufacturing locations. Collaborated internally with attorneys, site-specific buyers, engineers, and sourcing team members. Completed training related to Regulatory requirements (FDA, EU MDR, etc.), internal and external audits, quality management system standards (ISO 9001, ISO 13485, etc.), and Oracle Product Lifecycle Management software. Served as a subject matter expert and implementation lead as the organization transitioned to a globally shared, Agile-based supplier documentation management database. Show less



Barnes & Noble, Inc.

• United States
• Retail
• 700 & Above Employee

• Bookseller

  • Nov 2015 - Aug 2016

  - Achieved corporate revenue goals and executed national sales promotions. - Provided excellent customer service while simultaneously completing assigned tasks ahead of schedule. - Filled in for and completed the regular duties of vacationing senior level employees and department heads. - Achieved corporate revenue goals and executed national sales promotions. - Provided excellent customer service while simultaneously completing assigned tasks ahead of schedule. - Filled in for and completed the regular duties of vacationing senior level employees and department heads.



The Kennedy Collective

• United States
• Non-profit Organizations
• 100 - 200 Employee

• Community Activities Coach

  • Jun 2012 - Sep 2013

  - Collected and analyzed cultural, educational, social and demographic data about the community to guide local program development. - Developed innovative programs and activities based on analysis of community needs and interests. - Planned and hosted community service activities including soup kitchen and food pantry visits. - Drafted timetables and work programs, as well as tracked hours and statistics of clients and employees. - Coordinated scheduling, marketing, contract logistics and maintenance of supplies and equipment. - Prepared weekly written and oral reports about community service programs for supervisors. Show less



Covidien

• North Haven, CT

• Post Market Vigilance Document Preparation Coordinator

  • Jun 2011 - Aug 2011

  - Coordinated a document preparation program to meet the request of the Department of Justice regarding product acquisition. - Reported metrics related to the performance of the document coordinator team to upper management. - Completed the time-sensitive project ahead of schedule and under budget. - Coordinated a document preparation program to meet the request of the Department of Justice regarding product acquisition. - Reported metrics related to the performance of the document coordinator team to upper management. - Completed the time-sensitive project ahead of schedule and under budget.